FDA 510(k)

正畸塑料托槽和附件

K号: K180718 · 2018-10-30

决定日期2018-10-30

产品代码DYW

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决定实质等同

器械摘要

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Tomy, Inc.. It received FDA 510(k) clearance on 2018-10-30 under 510(k) number K180718. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES?

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2018-10-30. The listed applicant is Tomy, Inc.. The 510(k) number is K180718.

When did ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES receive FDA 510(k) clearance?

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES received FDA 510(k) clearance on 2018-10-30, under 510(k) number K180718.

Who is the listed applicant for ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES?

The FDA 510(k) record lists Tomy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES?

The FDA product code for ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES is DYW.

列明Tomy, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K160615正畸陶瓷托槽 1.1

官方来源

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